- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307696
Self-Expanding Multi-Layered Partially Resorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment of Small and Medium Umbilical Ventral Hernias
April 25, 2014 updated by: Jan Bontinck, Algemeen Ziekenhuis Maria Middelares
Multicenter Prospective Clinical Registry To Evaluate The Safety And Efficacy Of A Self-Expanding Multi-Layered Partially Resorbable Absorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment Of Small And Medium Umbilical Ventral Hernias
Meshes-devices using dual-sided mesh technology have been developed for the specific indication of small ventral hernias.
The design of these meshes allows introduction of a mesh of appropriate size to cover the hernia defect, through a small incision.
This technique is very attractive for the surgeon and the patients because the mesh usually can be introduced through a nearly invisible scar in the umbilicus.
The avoidance of fixation sutures omits the pain related to these sutures.
Short-term results and patient satisfaction are very favorable, encouraging the surgeons to continue with the technique, although long-term results of these meshes in good quality studies are lacking.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study is to evaluate the safety and efficacy at 12 months after repair of small and medium ventral hernias using PVP™.
All patients operated between March 2009 and February 2011 at the participating centers, will be evaluated and described.
Patients will be evaluated by clinical investigation, questioning and ultrasound.
The investigators' main focus will be the incidence of complications related to the use of the device, during the first year.
Also the investigators look at recurrence rate at 12 months, occurrence of pain at 12 months and foreign body feeling.
The trial can be seen as a quality control of a cohort of patients treated with an innovative mesh device.
No sponsoring from the company J&J will be asked or accepted.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oost Vlaanderen
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Ghent, Oost Vlaanderen, Belgium, 9000
- AZ Maria Middelares
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011, are eligible for the trial.
Description
Inclusion Criteria:
- All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011.
Exclusion Criteria:
- no informed consent from the patient.
- patients lost to follow up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hernia recurrence
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jan Bontinck, Algemeen ziekenhuis Maria Middelares
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 2, 2011
First Posted (Estimate)
March 3, 2011
Study Record Updates
Last Update Posted (Estimate)
April 28, 2014
Last Update Submitted That Met QC Criteria
April 25, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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